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# Kite’s Tecartus for Mantle Cell Lymphoma Gets Full Approval
- URL: https://www.fdaweb.com/kites-tecartus-for-mantle-cell-lymphoma-gets-full-approval/
- Published: 2026-04-02T12:00:00.000Z
- Updated: 2026-09-14T13:36:38.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160926

FDA has granted full approval for Kite’s CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL), converting its prior accelerated approval into a traditional approval based on confirmatory clinical data.

The decision is based on updated results from the ZUMA-2 study, including new data from Cohort 3, which evaluated patients who had not previously received Bruton tyrosine kinase inhibitors (BTKi), according to the company. FDA ruled that the totality of evidence — including efficacy, safety, and pharmacokinetics — demonstrated high response rates, durable remissions, and a safety profile consistent with earlier findings, it says.

The approval fulfills Kite’s post-marketing requirement under the accelerated approval pathway, which required verification of clinical benefit in a confirmatory trial. With the inclusion of Cohort 3 data in the label, Tecartus is now positioned for use earlier in the treatment sequence, including in patients who are BTKi-naive.

Kite says the clinical data from ZUMA-2 showed strong outcomes across patient groups. In heavily pretreated patients (Cohort 1), the therapy achieved an overall response rate (ORR) of 87% and a complete remission rate of 62%. In the less heavily treated, BTKi-naive population (Cohort 3), ORR reached 91% with a 79% complete remission rate. Median duration of response had not yet been reached in either cohort, suggesting sustained benefit over time.

Mantle cell lymphoma is a rare and aggressive form of non-Hodgkin lymphoma that primarily affects older adults and is often difficult to treat after relapse.